Identity
- Trade Name
- FUJIFILM FDA UDI
- Generic Name
- Flexible video bronchoscope, reusable FDA UDI
- Device Name
- The device is intended for the observation, diagnosis, and endoscopic treatment of trachea and bronchial tree FDA UDI
- Model / Reference
- EB-530H FDA UDI
- Description
- The device is intended for the observation, diagnosis, and endoscopic treatment of trachea and bronchial tree FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04547410330168 FDA UDI
- FDA Product Code
- EOQ FDA UDI
- GMDN Term
- Flexible video bronchoscope, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4680 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Flexible video bronchoscope, reusable
Fujifilm by FUJIFILM Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flexible video bronchoscope, reusable.
- EVIS EXERA BRONCHOVIDEOSCOPE — Olympus Medical Systems Corporation · Class II
- PENTAX Medical — HOYA CORPORATION · Class II
- PENTAX — HOYA CORPORATION · Class II
- VIDEO BRONCHOSCOPE — PENTAX of America, Inc. · Class II
- VIDEO BRONCHOSCOPE — PENTAX of America, Inc. · Class II
- VIDEO BRONCHOSCOPE — PENTAX of America, Inc. · Class II
- EVIS EXERA II BRONCHOVIDEOSCOPE — Olympus Medical Systems Corporation · Class II
- EVIS EXERA II BRONCHOVIDEOSCOPE — Olympus Medical Systems Corporation · Class II
Cleared under the same submission
K122535 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- FUJIFILM Corporation
Sources (1)
- FDA UDI 7f4b6295-77f9-4780-9ebe-6cf0f133884c 36 fields · synced Jun 1, 2026